Status:
COMPLETED
Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
The primary objective of this non-interventional study (NIS) is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD ...
Eligibility Criteria
Inclusion
- Female and male patients ≥40 years of age
- Patients diagnosed with COPD who have been using tiotropium administered with Spiriva® Handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with Spiolto® Respimat® has been made
- Written informed consent prior to participation
- Patient should be able to read, comprehend and complete study questionnaires
Exclusion
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with inhaled corticosteroids (ICS) as maintenance therapy\* or with a Long-acting beta2 adrenoceptor agonist (LABA)/Long-acting muscarinic antagonist (LAMA) combination (free or fixed dose) in the previous 6 weeks
- \*Note: patients with temporary corticosteroids (CS) use during acute exacerbations in the previous 6 weeks can enter the study
- Patients who have been treated with Spiriva® Respimat®, with other LAMA different than Spiriva®, or with a combination of Spiriva®+LABA/ICS in the previous 6 weeks
- Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
- Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
- Pregnancy and lactation
- Patients currently listed for lung transplantation
- Current participation in any clinical trial or any other non-interventional study of a drug or device.
- Further exclusion criteria apply.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
1396 Patients enrolled
Trial Details
Trial ID
NCT04672941
Start Date
February 16 2021
End Date
February 21 2022
Last Update
June 25 2024
Active Locations (2)
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1
Metropolitan Hospitsal, PNOI Pulmonology Clinic
Athens, Greece, 185 47
2
European Interbalkan Medical Center, Pulmonology Clinic
Thessaloniki, Greece, 555 35